Freelance Clinical Research Associate

ClinChoice is seeking an experienced Freelance Clinical Research Associate (CRA) to monitor a Phase I oncology trial. This is a full-time (1.0 FTE), remote position for a U.S.-based CRA, with approximately 70% travel to investigative sites. Opened to 1099 independent contractors. Experience in monitoring Phase I oncology trials, including CAR T studies, is required. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. Main Job Tasks and Responsibilities:

• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
• Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate.
• Train site staff in all study procedures.
• Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
• Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
• Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
• Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• Act as the main contact person for the site to ensure close follow up.
• Provide general support to the Clinical Research Division on quality control of clinical data.
• Address appropriate team members about any issues that can jeopardize the conduct of the clinical projects assigned in a timely manner.
• Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• Develop training material and give training in collaboration with the Training & Qualification Management Unit.
• May assist with contract negotiation with sites on study budget after appropriate training.
• Assist with the preparation of the study, including CRF design/development, write CRF instructions and organize the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project including submission requirements, timelines, informed consent development, etc.

Education, Experience and Skills:

• University Degree in scientific, medical or paramedical disciplines.
• Eight (8) years (at least) of experience as a CRA.
• Advanced oncology experience required, including experience with Phase 1 oncology trials.
• Experience monitoring CAR T studies is required.
• Proven experience as a CRA, performing on-site monitoring activities.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Fluent in English.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel 70% of the time.

The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Clinical Research Associate, CRA, Freelance, Permanent, CRO, Contract Research Organization, Outsourced, Outsourcing, Oncology, Monitoring, Phase I Oncology Trials, Senior CRA, Oncology Clinical Trials, Early Phase Trials, Investigative Site Monitoring, On-site Monitoring, Remote Monitoring, 1.0 FTE, 70% Travel, 1099, Independent Contractor, GCP (Good Clinical Practice), ICH Guidelines, FDA Regulations, Regulatory Compliance, Clinical Trial Operations, Source Data Verification (SDV), Case Report Forms (CRFs), Data Query Resolution, Safety Reporting (AE, SAE, SUSAR), Investigational Product (IP) Management, Site Initiation Visits (SIV), Site Selection Visits (SSV), Close-Out Visits (COV), Feasibility Assessment, Site Management, Study Start-Up, Clinical Data Quality Control, Monitoring Visit Reports, Investigator Study File (ISF), Trial Master File (TMF), Clinical Study Documentation, Site Training, Study Budget Negotiation, Informed Consent Development, Submission Support, 8+ Years CRA Experience, Advanced Oncology Experience, Phase I Oncology Monitoring, Early-Phase Oncology Trials, CRO Experience, U.S.-Based CRA #LI-VH #LI-Remote #Freelance Clinical Research Associate # Contract Apply tot his job Apply To this Job